Articles from Validation Times (July 1, 2001)

1-27 out of 27 article(s)

Title	Author	Type	Words
510(k)s.		Brief Article	59
Analysis of 483s/EIRs for GMP validation issues.	McCarty, Mark		1428
Audit custom code, vendor/customer partnering urged.	Flickinger, Bruce	Brief Article	611
CAPAs, SOPs trip Prosec; firm didn't reply to 483.		Brief Article	207
Catheter firm delineation of design process faulted.		Brief Article	279
Chemrich water validation hit after 10-year audit lapse.		Brief Article	51
Development guide seen adopted by ISO after ANSI.	Beck, Ellen	Brief Article	689
Drugs/CBER.		Brief Article	150
Electronic 'tagging' for record changes seen as FDA desire.	Whipple, Dan; Beck, Ellen	Brief Article	806
Electronic Records/Computer-Software Validation.			163
FDA follow-up to MedWatch report nets Alaris warning.		Brief Article	940
FDA seen enforcing draft inhaler guide, extractable limits.	Flickinger, Bruce		1065
FDAer says firms should go beyond 'functional testing'.	Whipple, Dan	Brief Article	668
Firms urged to use ISO 9001 for biz, 13485:200x for FDA.	Beck, Ellen	Brief Article	441
IVAX flow characteristics, validation, OOS get cited.		Brief Article	403
IVD maker Meridian hit on lyophilization validation.		Brief Article	436
Medical Devices.		Brief Article	202
Part 11 appears to figure in blood bank warning.		Brief Article	411
Stability Over 26% of NDAs lack stability data; Q1A helps little.	Whipple, Dan	Brief Article	489
Stability, cleaning subject of warning to Marianna.		Brief Article	103
Swedish company hit for media fill qualification's 'worst-case' validation.		Brief Article	755
Theratest sterile water for IVDs gets FDA warning.		Brief Article	244
Transplant foundation hit on residual EtO, signature.		Brief Article	309
Tyco subsidiary Lafayette warned on OOS issues.			139
USP tightens rules on temperatures for drug packages.	Flickinger, Bruce	Brief Article	857
Warning Letter Analysis.		Brief Article	507
Zenith did not validate 13 batches of stability drugs, FDA charges in warning.		Brief Article	161